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NCT00943878 · ClinicalTrials.gov registry record · Phase 2
Sanofi H1N1 + TIV - Adults and Elderly
A Phase 2 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 805
- Enrollment target
- 5
- Study locations
NCT00943878: Completed Phase 2 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00943878 is a Phase 2 study of Influenza that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 805 participants, below the 36,799-participant average among 156 other Influenza trials with a reported enrollment target (98% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00943878, a Phase 2 study of Influenza, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 805 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this study is to assess the safety and immune response (body's defense against disease) to an experimental H1N1 influenza vaccine against the 2009 H1N1 virus. This study will help determine how the H1N1 flu shot should be given with the seasonal flu shot to make it most effective. Participants will include up to 850 healthy adults, ages 18 and older. Participants will receive 2 H1N1 vaccines in addition to placebo (inactive substance) and the seasonal flu shot over 3 study visits about 21 days apart. Study procedures include: medical history, physical exam, maintaining a memory aid, and blood sample collection. Participants will be involved in the study for about 8 months.
Primary Outcome
Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL Trivalent inactivated influenza vaccine
- BIOLOGICAL Inactivated H1N1 Vaccine
Study Locations (5)
Georgia
- Emory Vaccine Center - The Hope Clinic - Decatur
Missouri
- Saint Louis University Hospital - Internal Medicine - Infectious Diseases, Allergy & Immunology - St Louis
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Tennessee
- Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center - Nashville
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 805 participants |
| Start Date | 2009-08 |
| Est. Completion | 2010-04 |
| Phase | Phase 2 |
What the finished NCT00943878 record still lists
NCT00943878 is an interventional study that assigns participants to a tested intervention. The registered 805 participants enrollment target is mid-sized for trials with a published cap, below the 36,799-participant average among 156 other Influenza trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00943878 lists 5 locations in 5 states (Georgia, Missouri, Ohio).
Frequently Asked Questions
What is clinical trial NCT00943878 about?
NCT00943878 is a clinical study titled "Sanofi H1N1 + TIV - Adults and Elderly". The purpose of this study is to assess the safety and immune response (body's defense against disease) to an experimental H1N1 influenza vaccine against the 2009 H1N1 virus. This study will help determine how the H1N1 flu shot should be given with the seasonal flu shot to make it most effective. Par...
What is the current status of trial NCT00943878?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 805 participants. The study started on 2009-08. Estimated completion is 2010-04.
What conditions does trial NCT00943878 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT00943878?
The interventions under investigation include: Placebo (DRUG), Trivalent inactivated influenza vaccine (BIOLOGICAL), Inactivated H1N1 Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00943878?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00943878 being conducted?
This trial has 5 study locations across Georgia, Missouri, Ohio, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00943878's enrollment target sits among peer trials
805 40th of 156 higher than 117 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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